Supplier Quality Engineer

Siemens Healthineers; Llanberis; On-site; GBP 42,000 - 62,000; Full time

Benefits offered by this job

26 days' holiday with option to buy/s-

Up to 10% employer pension

Share and bonus scheme

Flexible benefits: private medical, or

CSR volunteering days + EAP

Job summary

Siemens Healthineers in Llanberis, Wales, is seeking a Supplier Quality Engineer to strengthen supplier quality management within an ISO 13485 and FDA-regulated environment. You will collaborate with engineering, production and procurement to ensure high-quality parts from suppliers meet internal standards.

This role supports technology transfer, supplier audits, root-cause investigations and cross-functional collaboration to drive continuous quality improvements across the supply chain at our

Qualifications

• Previous experience in a supplier facing Quality Engineering role.
• Ability to work in technically complex areas across the whole supply chain.
• Excellent communication skills both oral and written.
• Auditing experience to ISO 9004:2015 and ISO 13485:2016.

Responsibilities

• Develop world-class supply chain processes between a low volume, high complexity multi-technology environment and a higher volume allergen manufacturing (reagents).
• Manage suppliers to deliver quality products through investigations and evaluations.
• Liaise with external suppliers to ensure training and adherence to First Articles, Quality and Regulatory requirements.
• Issue Supplier Corrective Action Reports and work with suppliers on root cause investigations and corrective actions.
• Conduct Supplier Performance Reviews and reporting of Key Supplier Quality metrics.
• Support technology transfer initiatives and projects; assess and select new suppliers.
• Provide day-to-day inspection expertise support to Goods Inwards Inspection Team for Components and Mechatronic Inspection.
• Contribute to continuous development of the quality system and SOPs; write concise technical reports.
• Oversee KPIs for supplier quality oversight and ensure requirements are met.

Skills

Supplier quality engineering

Auditing ISO 13485

Communication skills

Complex supply chain

Education

HNC/Diploma/Degree

Job description

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Siemens Healthineers has an opening for a Supplier Quality Engineer at our In-Vitro Diagnostic (IVD) instrumentation / reagent manufacturing site in Llanberis, Gwynedd, North Wales. The Supplier Quality team works cross functionally with engineering, production, and procurement with responsibilities focused on maintaining a high level of delivered quality parts from our suppliers.

This role will support our supplier quality management services within an ISO 13485 and FDA 21 CFR Part 820 regulatory environment.

Your Role:

• To develop world-class supply chain processes between a low volume, high complexity multi-technology environment (diagnostic instrumentation) and a higher volume allergen manufacturing (reagents.)
• To manage our suppliers to deliver quality product to our internal customers, through product & process investigations & evaluations.
• Liaising with a wide variety of external suppliers to ensure suppliers are trained and adhere to Siemens First Articles, Quality and Regulatory requirements.
• Issuing of Supplier Corrective Action Reports and working with suppliers on Root Cause Investigations and Corrective action.
• Conducting Supplier Performance Reviews and Reporting of Key Supplier Quality metrics.
• To support technology transfer initiatives and new projects. Involving the assessment and selection of new suppliers where applicable.
• To provide day to day inspection expertise support to the Goods Inwards Inspection Team in the areas of Component and Mechatronic Inspection and acting as a technical reference to interface with the supplier.
• To contribute to the continuous development of the quality system, including standard operating procedures (SOP's) coupled with the ability to write concise technical reports.
• Support a Strong Supplier focus to ensure that that our requirements are met appropriately and oversee relevant KPIs for supplier quality oversight.

Your Expertise:

• Previous experience in a supplier facing Quality Engineering role.
• HNC/Diploma/Degree in an appropriate discipline OR commensurate experience.
• Ability to work in technically complex areas across the whole supply chain, including the supplier environment.
• Excellent Communication skills both oral and written.
• Auditing experience to both ISO 9004:2015 and ISO 13485:2016.

  Our Benefits:

  • 26 days' holiday with the option to buy or sell an additional 5
  • Up to 10% employer pension contribution
  • Share and bonus scheme
  • Access to our flexible benefits from private medical insurance to dental cover
  • Corporate Social Responsibility opportunities including 2 paid volunteering days per year and support from our 24/7 employee assistance programme

  Who we are:

  We are a team of more than 71,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

  How we work:

  When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

  As an equal opportunity employer, we welcome applications from individuals with disabilities.

  To all recruitment agencies:

  Siemens Healthineers' recruitment is internally managed, with external support permitted only when a qualified supplier has established a formal contract with us. Unsolicited candidate submissions and referrals, absent a current supplier contract, do not establish consent and are ineligible for fees. We delete and destroy unsolicited information, thus, would recommend you refrain from any such practices. Your adherence to our policies is appreciated.